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Trial record 3 of 251 for:    "Aphasia"

The Usage of High-resolution Magnetic Resonance Imaging in Patients With Post-stroke Aphasia for Predicting the Outcome

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ClinicalTrials.gov Identifier: NCT03475745
Recruitment Status : Active, not recruiting
First Posted : March 23, 2018
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Zhejiang University

Brief Summary:
Combined analysis of functional and structural language network changes may be a good model for predicting language outcome.

Condition or disease
Aphasia

Detailed Description:

Background & objectives:

Language impairment after aphasic stroke is both common and debilitating. However the mechanisms of language recovery after aphasic stroke is not fully understood. Investigators plan to detect the changes of functional and structural language networks after aphasic stroke by high-resolution MRI.Then Combined analyse functional and structural language network changes, establishing a prediction model for language outcome.

Methods:

The proposed study is a observational trial that will include 50 patients diagnosed with post stroke aphasia from the neurology clinics at The First Affiliated Hospital, Zhejiang University. Aphasia battery of Chinese(ABC) and functional magnetic resonance imaging (MRI) will be performed at acute(~2weeks),subacute(3 months) and chronic phase(6months). Only routine drug therapy will be used.

Relevance:

Currently there is little known about the recovery mechanisms of post-stroke aphasia.The proposed study intends to analyse functional and structural language network changes by high resolution MRI, which may reveal the potential recovery mechanism underlying post stroke aphasia..


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Usage of High-resolution Magnetic Resonance Imaging in Patients With Post-stroke Aphasia for Predicting the Outcome
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia MRI Scans

Group/Cohort
Aphasia
Post stroke aphasia patients without any additional interventions for research purposes.
Control
Healthy controls



Primary Outcome Measures :
  1. Resting state functional connectivity changes [ Time Frame: 3 months ]
    The study uses resting state functional MRI(rs-fMRI) to measure changes of functional connectivity across regions after a spontaneous recovery.


Secondary Outcome Measures :
  1. Aphasia Battery of Chinese, ABC [ Time Frame: 3 months ]
    ABC, the Chinese standardized adaptation of the Western Aphasia Battery, indicates the patient's ability of spontaneous speech, auditory comprehension, repetition, naming, reading, writing.

  2. White matter Integrity [ Time Frame: 3 months ]
    The study uses Diffusion tensor imaging and tracking (DTI) to measure changes of the Integrity of white matter after a spontaneous recovery.

  3. Brain response change [ Time Frame: 3 months ]
    The study uses task functional MRI (fMRI) to measure the brain response changes during the task after a spontaneous recovery.

  4. Resting state functional connectivity changes [ Time Frame: 6 months ]
    The study uses resting state functional MRI(rs-fMRI) to measure changes of functional connectivity across regions after a spontaneous recovery.

  5. Aphasia Battery of Chinese, ABC [ Time Frame: 6 months ]
    ABC, the Chinese standardized adaptation of the Western Aphasia Battery, indicates the patient's ability of spontaneous speech, auditory comprehension, repetition, naming, reading,

  6. White matter Integrity [ Time Frame: 6 months ]
    The study uses Diffusion tensor imaging and tracking (DTI) to measure changes of the Integrity of white matter after a spontaneous recovery.

  7. Brain response change [ Time Frame: 6 months ]
    The study uses task functional MRI (fMRI) to measure the brain response changes during the task after a spontaneous recovery.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
In-patients from Neurology departments of the First Affiliated Hospital, Zhejiang University
Criteria

Inclusion Criteria:

  • Healthy right-handed native Chinese speakers with more than 6-year education are recruited as healthy controls.

Exclusion Criteria:

  • Not right-handed;
  • Any use of psychoactive drugs;
  • Less than 6-year education;
  • Not suitable for MRI scan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475745


Locations
China, Zhejiang
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Investigators
Principal Investigator: Benyan Luo, Ph.D The First Affiliated Hospital, Zhejiang University

Responsible Party: First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT03475745     History of Changes
Other Study ID Numbers: HRMRI- aphasia
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital of Zhejiang University:
resting-state
DTI
aphasia
stroke

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms